Prospective NIS to Generate Real-World-Data on Effectiveness and Safety of First-line Therapy With Chemotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab or Durvalumab + Olaparib in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 150
- 试验地点
- 50
- 主要终点
- Real-world Time To Next Treatment (rwTTNT)
研究概览
简要总结
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin/Paclitaxel/Durvalumab (CPD) followed by maintenance therapy with durvalumab or durvalumab and olaparib in line with the applicable european summary of product characteristics (SmPC). Additionally, patient-reported outcomes after 1L treatment with CPD will be assessed.
详细描述
This is a multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and PRO data in patients with primary advanced (FIGO stage III or IV) or recurrent EC receiving 1L CPD followed by maintenance therapy with durvalumab (DNA mismatch repair deficient; dMMR cohort) or durvalumab and olaparib (DNA mismatch repair proficient, pMMR cohort) in accordance with the applicable SmPC within routine clinical practice. Following surgery and/or radiation (if applicable) the decision to initiate 1L CPD followed by durvalumab or durvalumab and olaparib is made in a shared decision between the patient and the treating physician as part of routine care outside of and independent of this study.
The aim of the NIS is to describe the outcomes including effectiveness and safety of patients with primary advanced and recurrent EC treated with the two approved 1L regimens of CPD followed by durvalumab maintenance and CPD followed by durvalumab and olaparib maintenance, as well as patient-reported outcomes after chemotherapy-phase (CPD) in Germany. The study also aims to better understand characteristics of patients with primary advanced or recurrent EC that benefit from maintenance therapy with durvalumab or durvalumab and olaparib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years at the time of screening.
- •Patient has pathologically documented:
- •Primary advanced (FIGO III and IV) epithelial EC OR
- •Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed,
- •Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% for each cohort of the study population.
- •Patient is eligible for treatment with durvalumab and/or olaparib as specified in the IMFINZI® and Lynparza® SmPC. The prescription of the medicinal product is clearly separated from the decision to include the patient in the study.
- •MMR-testing results of the patient's tumor are known.
- •Patient is willing and able to complete PRO questionnaires.
- •Patient can read and understand German, English, Arab, Russian or Turkish.
- •Signed written informed consent.
排除标准
- •Patient has already received >2 cycles of 1L CPD
- •Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug.
- •Pregnancy or breast-feeding.
- •Unable to swallow orally administered medication.
- •Current or planned participation in an interventional clinical trial.
- •Current or planned systemic treatment of any tumor other than primary advanced or recurrent EC.
- •Patient has pathologically documented sarcoma
研究组 & 干预措施
DNA mismatch repair proficient (pMMR)
Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested pMMR status. Following the SmPC patients of this cohort will receive durvalumab and olaparib in the maintenance phase if they achieved and maintained disease control i.e., CR, PR, or SD with CPD during the chemotherapy phase.
DNA mismatch repair deficient (dMMR)
Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested dMMR status. Following the SmPC patients of this cohort will receive durvalumab in the maintenance phase if they achieved and maintained disease control, i.e., complete response (CR), partial response (PR), or stable disease (SD) with CPD during the chemotherapy phase.
结局指标
主要结局
Real-world Time To Next Treatment (rwTTNT)
时间窗: At 12 months
rwTTNT is defined as time from start of 1L CPD until first dose of next systemic therapy or start of any other next anticancer therapy or death from any cause. 1L maintenance therapy with durvalumab or durvalumab+olaparib is not considered as next systemic therapy. The measure of interest is the landmark at 12 months of time to first next therapy or death (rwTTNT).
次要结局
- Real-world Progression-free Survival (rwPFS)(At 12 months)
- Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time(Baseline to first clinically meaningful deterioration, up to 46 months)
- Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time(Baseline to first clinically meaningful deterioration, up to 46 months)
- Duration of maintenance therapy(From first dose of maintenance therapy up to 46 months)
- Duration of 1L CPD(Assessed up to 46 months)
- Time between end of CPD until start of maintenance therapy(Assessed up to 46 months)
- Usage of treatment therapy(Assessed up to 46 months)